a study of doxil, vincristine and decadron (dvd) +/ cc-5013 in relapsed refractory multiple myeloma (mm)

Conditions: Multiple Myeloma

Summary: a phase i study of cc-5013 in combination with doxil, vincristine and decadron (dvd) in subjects with relapsed or refractory multiple myeloma


Eligibility criteria:
inclusion criteria: * understand and voluntarily sign an informed consent form. * age greater than 18 years at the time of signing the informed consent form. * able to adhere to the study visit schedule and other protocol requirements. * diagnosed with active multiple myeloma and be considered to have disease progression after at least 2 cycles of anti-myeloma treatment or have relapsed with progressive disease after treatment. * measurable myeloma paraprotein levels in serum (≥ 0.5g/dl) or urine (≥ 0.2 g excreted in a 24-hour collection sample). * eastern cooperative group (ecog) performance status of 0-2. performance status of 3 and 4 will be allowed if related to bony disease. * bilirubin \< 2 x upper limits of normal (uln). * liver enzymes (alt or ast) \< 3 x uln. * must have adequate bone marrow function: \* absolute neutrophil count \> 1,000 cells/mm3 (1.0 x 109/l) \* platelets ≥ 100,000 cells/mm3 (100 x 109/l) \* hemoglobin ≥ 8 g/dl * must have adequate renal function: creatinine ≤ 2.5 mg/dl. * must have 2-d echocardiogram indicating lvef ≥ 50% within 42 days prior to first dose of study drug. * women of childbearing potential (wcbp) must have a negative serum or urine pregnancy test within 7 days of starting study drug. in addition, sexually active wcbp must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug. wcbp must agree to have pregnancy tests every 4 weeks while on study drug. exclusion criteria: * severe infection requiring intravenous antibiotic treatment. * life expectancy of less than 3 months. * prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, or other cancer from which the subject has been disease-free for at least 5 years. * solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia. * subjects who have received \> 500mg/m2 of doxorubicin alone, or doxil® alone, or doxorubicin plus doxil®. * prior treatment with cc-5013. * prior development of ≥ grade 2 (nci ctc) allergic reaction/hypersensitivity while taking thalidomide. * prior development of a ≥ grade 3 (nci ctc) rash or any desquamation while taking thalidomide. * history of cardiac disease, with new york heart association class ii or greater. * uncontrolled medical problems such as diabetes mellitus, coronary artery disease, hypertension, unstable angina, arrhythmias), pulmonary, hepatic and renal diseases unless renal insufficiency is felt to be secondary to multiple myeloma. * any investigational agent or systemic anti-myeloma therapy within 28 days of the first dose of treatment. * any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. * pregnant or lactating females. * any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.

Keywords: cc-5013 cc5013 revlimid lenalidomide multiple myeloma